Using FDG-PET During Radiation Therapy in Non-Small Cell Lung Cancer

Non-Small Cell Lung Cancer Clinical Trial

— HUM15709  

Official title:

Using FDG-PET Acquired During the Course of Radiation Therapy to Individualize Adaptive Radiation Dose Escalation in Patients With Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01190527
• Other study ID #: UMCC 2007.123
• Status: Active, not recruiting
• Phase: N/A
• First received: April 1, 2010
• Last updated: May 14, 2015
• Start date: August 2008
• Est. completion date: August 2015

Study information

• Verified date: May 2015
• Source: University of Michigan Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Successful treatment of non-small cell lung cancer with radiation therapy requires that the physicians determine exactly where the tumor is in your body, and protect your normal tissue. This study is designed to apply functional imaging, Fluorodeoxyglucose-Positron Emission Tomography (FDG-PET) before treatment, and then again during treatment to see if the procedure helps predict how well the treatment works for your cancer and how well your lung functions during treatment. FDG-PET is a modern technology that uses small amounts of a radioactive glucose (FDG) to make images of your whole body and areas of active cancer. A Computerized Tomography (CT) will also be performed along with both of these procedures to help the researchers see clearly where your cancer or your healthy lung is located. The study will help the investigator determine whether an adaptive plan that is applied based on repeat PET-CT imaging during the course of radiation therapy (during RT), can show if there is an improvement in treatment outcome compared to those treated with standard radiation therapy. This adaptive plan may allow your doctor to escalate the dose per treatment and the total dose of your treatment based on the risk of damage to your healthy lung tissue. While increasing the radiation dose, but limiting the toxicity to normal lung tissue, the researchers hope to improve your tumor control.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 42
• Est. completion date: August 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must have FDG-avid and pathologically proven non-small cell lung cancer. If pathology not definitive, the patient needs to have a clinically diagnosed non-small cell lung cancer, which is also FDG-avid.

• Patients must be 18 years of age or older.

• Patients must have Karnofsky performance score > 60.

• Patients must have clinical AJCC (American Joint Committee on Cancer) Stage I-IIIB, with unresectable or inoperable disease.

• Patients must have no evidence of a malignant pleural or pericardial effusion

• Patients must have hemoglobin > 10 gm/dl. Transfusions or medications may be used to achieve this criterion.

• Patients must have reasonable organ and marrow functions as defined below if chemotherapy is considered:

• WBC (White Blood Cell) > 3,000/mm3.

• absolute neutrophil count = 1,500/mm3.

• platelets > 100,000/mm3

• total bilirubin = 3.0 mg/dl.

• AST ( Aspartate Aminotransferase or SGOT) and ALT (Alanine Transaminase or SGPT) < 4 X institutional upper limit of normal.

• creatinine = 2.0 mg/dl.

• Patients must not have serious intercurrent diseases per the judgment of the treating physician.

• Patient must be willing to use effective contraception if female with reproductive capability.

• Patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria:

• Patients with any component of small cell lung carcinoma are excluded from this study.

• Prior radiotherapy to the thorax such that composite radiation would significantly overdose critical structures, either per estimation of the treating radiation oncologist or defined by failure to meet normal tissue tolerance constraints.

• Pregnant women are excluded from this study because radiation has the potential for teratogenic or abortifacient effects.

• Prisoners are excluded for this study.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Radiation:
• FDG-PET
This study is designed to apply functional imaging, Fluorodeoxyglucose-Positron Emission Tomography (FDG-PET) before treatment and again during treatment to see if it helps predict how well the treatment works for the cancer. The standard of care for patients with stage III unresectable NSCLC is combined chemoradiotherapy. This study will seek to determine 2 year local-regional progression free survival in patients with non-small cell lung cancer (NSCLC) when an adaptive plan is applied based on repeat PET-CT imaging during the course of radiation therapy (during RT), and investigate if there is an improvement compared to those treated with conventional radiation therapy without field and/or dose modification. The investigators hypothesize that during-RT, PET-CT-based adaptive therapy will allow them to dose escalate in the majority of patients and meet the dose limits of normal structures, thus improving local tumor control without increasing toxicity.

Locations

Country	Name	City	State
United States	University of Michigan Cancer Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients With Overall Local-Regional Tumor Control at 2 Years Using FGD-PET-CT During Radiation Therapy(RT)	Use FGD-PET-CT based adaptive radiation to deliver a higher total dose to the active tumor to determine if it will improve the local-regional tumor control and progression-free survival in patients, without increasing the normal tissue complication probability (NTCP) of the lung.	2-5 years	No
Secondary	Number of Patients That Were Able to Receive Dose Escalation	Total biological equivalent dosing difference between the 6-week prescribed plan using pre-RT imaging, will be compared to the dose delivered using the adaptive planning technique. At a minimum, the number of patients for which dose escalation was possible will be reported, along with the mean and standard deviation in the dose increase for the population.	2 Years	No
Secondary	Correlation Between Pre-Radiation Therapy Tumor Sizes	Correlations between pre-radiation therapy tumor sizes, distance from important anatomical structures and the dose increase, may be explored using the rank method of Spearman. Overall survival of all patients will be estimated using the product-limit method of Kaplan and Meier.	2-5 years	No
Secondary	Toxicities	Toxicities will be reported as proportions with exact binomial confidences intervals. Standard unconditional logistic regression techniques will be used to explore potential associations between the levels of transforming growth factor beta one, and other molecules the occurrence of treatment-related toxicity. The relationship will be explored by dichotomizing toxicity events by meaningful grade and/or by the type of toxicity (e.g. pneumonitis vs. fibrosis.	2-5 years	No

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